CTEP Visiting Physician Externship Coordinator: Igor Espinoza-Delgado, M.D. NCI CTEP Investigational Drug Branch

Activities for Physicians Visiting CTEP Visiting physicians (VPs) are involved in the day to day operations of CTEP In close collaboration with Sr. Clinical Investigators, VPs will be asked to: –Sign a confidentiality agreement –Provide review of incoming protocols and LOIs –Be present for internal meetings and for discussion between CTEP and pharmaceutical companies in evaluation of new agents –Participate in discussions between CTEP and FDA regarding the development of new agents –Observe concept reviews in which prioritization of cooperative group phase III clinical trials are taken

Investigational Drug Branch Responsible for: – Implementation and monitoring of a comprehensive cancer therapy clinical program that sponsors clinical trials of novel agents that have demonstrated high activity in relevant pre-clinical models. – Creation of drug development plans (Phase I, II, and III trials) for anti-cancer drugs and coordination of both intramural and extramural investigators and the pharmaceutical industry in the design and the conduction of these trials. – Reports concerning adverse events (AEs) for all INDs. – Annual reports to FDA on oncologic drugs

Current CTEP Workload Average # of documents received per month over the last 5 months: – Concepts - 6 – LOIs – 16 – Protocols – 21 – Revisions – 55 – Amendments As of May 2010, there are approximately 1145 ongoing CTEP sponsored studies

Typical week MondayTuesdayWednesdayThursdayFriday *OEWG TCCompany meetings OEWG TC IDB-LOIs Concept Review Protocol Review Consensus PD meetings OEWG TC Company meetings Translation. Research Program (Intramural) CTEP Program Meetings CTEP-FDA Monthly Meeting *Operational Efficiency Working Group teleconferences